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Comparison of the Efficacy and Safety of Ivermectin to Permethrin
This study has been completed.
Sponsor:
University Ghent
Information provided by:
University Ghent
ClinicalTrials.gov Identifier:
NCT00262418
First received: December 4, 2005
Last updated: December 19, 2007
Last verified: December 2007
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Purpose
Comparison of the efficacy and safety of a single administration of ivermectin to a single administration of permethrin for the treatment of scabies
| Condition | Intervention | Phase |
|---|---|---|
| Scabies | Drug: Administration of ivermectin or permethrin | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Double Primary Purpose: Treatment |
| Official Title: | A Randomised, Double Blind, Double Dummy Study to Compare the Efficacy and Safety of a Single Administration of Ivermectin to a Single Administration of Permethrin for the Treatment of Scabies |
Resource links provided by NLM:
Further study details as provided by University Ghent:
Primary Outcome Measures:
- Clinical healing of the skin injuries [ Time Frame: on day28 ]
Secondary Outcome Measures:
- Decrease of itching [ Time Frame: on day28 ]
- Amelioration of the life quality [ Time Frame: on day28 ]
- Number and gravity of adverse events
| Enrollment: | 160 |
| Study Start Date: | July 2004 |
| Study Completion Date: | May 2005 |
Administration of ivermectin or permethrin on day0 Clinical examination and pictures on day0, day14 and day28 Blood sample on day0 VAS for pruritus, DLQI and SF-36 on day0, day14 and day28
Eligibility| Ages Eligible for Study: | 5 Years and older (Child, Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
At least one of the following inclusion criteria:
- Scabies tunnels
- Positive microscopic examination (acarids, faeces or ova)
At least two of the three following inclusion criteria:
- Non-specific injuries with a typical distribution pattern
- Serious itching which increases during the night
- Family or contacts with similar complaints
Exclusion Criteria:
- Treatment for scabies < 4 weeks ago
- Treatment with corticoids < 1 week ago
- Pregnancy
- Breast-feeding
- HIV
- Serious immunodepressive patients
- Sensitivity or allergy to one of the components of the study medication
- Damage of the central nerve system
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00262418
Please refer to this study by its ClinicalTrials.gov identifier: NCT00262418
Locations
| Belgium | |
| University Hospital Ghent | |
| Ghent, Belgium, 9000 | |
Sponsors and Collaborators
University Ghent
Investigators
| Principal Investigator: | Jean-Marie Naeyaert, MD, PhD | University Hospital, Ghent |
More Information
Additional Information:
| ClinicalTrials.gov Identifier: | NCT00262418 History of Changes |
| Other Study ID Numbers: |
2004/212 |
| Study First Received: | December 4, 2005 |
| Last Updated: | December 19, 2007 |
Additional relevant MeSH terms:
|
Scabies Mite Infestations Ectoparasitic Infestations Skin Diseases, Parasitic Parasitic Diseases Skin Diseases, Infectious Skin Diseases |
Ivermectin Permethrin Antiparasitic Agents Anti-Infective Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on September 21, 2017